The Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity

Immunity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814617
• Other study ID #: CBG-PI-CME
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2016
• Last updated: June 23, 2016
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators performed randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-1β, IL-2, IL-4, IL-10, IL-12, IFN-γ, TNF-α).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males and females 20-75 years old

• Able to give informed consent

Exclusion Criteria:

• WBC concentration below 3000 ?, over 8000?

• Subjects with BMI < 18.5 kg/m2 at screening visit

• Allergic or hypersensitive to any of the ingredients in the test products

• Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes

• History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery

• History of alcohol or substance abuse

• Participation in any other clinical trials within past 2 months

• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

• Pregnant or lactating women etc.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immunity

Intervention

Dietary Supplement:
• Cordyceps sinensis mycelium culture extract 1.68 g
Cordyceps sinensis mycelium culture extract 1.68 g
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum natural killer cell activity		Baseline, 8 weeks	Yes
Secondary	Changes in Cytokine(IL-1ß, IL-2, IL-4, IL-10, IL-12, IFN-?, TNF-a)		Baseline, 8 weeks	Yes